Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market


“The Report Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market provides information on pricing, market analysis, shares, forecast, and company profiles for key industry participants. – MarketResearchReports.biz”

GBI Research’s report Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market looks at the regulatory landscape and reimbursement scenario in the US for four medical device markets: cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices.

The report provides comprehensive information on establishment registration, medical device listing, Premarket Notification (510k) or Premarket Approval (PMA), Investigational Device Exemption (IDE) for clinical studies, Quality System (QS) regulation, labeling requirements, and Medical Device Reporting (MDR). The report also reviews the reimbursement scenario in these medical device markets. It is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

View Report At :http://www.marketresearchreports.biz/analysis/167418

Scope

  • The report analyzes the regulatory and reimbursement scenario for medical devices in the US.

  • Information on the regulatory landscape in the US: establishment registration, medical device listing, Premarket Notification (510k) or PMA, IDE for clinical studies, QS regulation, labeling requirements, and MDR.

  • Information on reimbursement coverage in the US for cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices.

  • Annualized market revenue data, forecast to 2018, for the transcatheter heart valves market, left ventricular assist devices market and endoscopy devices market.

  • Qualitative analysis of key trends in the US regulatory and reimbursement landscape.

Reasons to Buy

  • Develop business strategies by understanding the reimbursement trends in the US medical devices market.

  • Design and enhance your product development, marketing, and sales strategies.

  • Develop market-entry and market expansion strategies.

  • Identify, understand and capitalize on the next big thing in the US medical devices market landscape.

  • Make more informed business decisions from the insightful and in-depth analysis of the US medical devices market and the factors shaping it.

Download Sample copy of this Report at : http://www.marketresearchreports.biz/sample/sample/167418

Table of Contents

1 Table of Contents 2

1.1 List of Tables 4

1.2 List of Figures 4

2 Executive Summary 5

2.1 Obtaining Marketing Clearance for Medical Devices Involves Three Essential Steps 5

2.2 The US Transcatheter Heart Valves Market is Forecast to Witness High Growth Between 2012 and 2019 due to Favorable Reimbursement 5

2.3 Strong Reimbursement Framework is Expected to Drive the US Endoscopy Device Market 6

3 Introduction 8

4 Overview of the Healthcare Reform Bill 9

5 Regulatory Landscape in the US 17

5.1 Overview of Medical Device Regulation 17

5.1.1 Establishment Registration 18

5.1.2 Medical Device Listing 19

5.1.3 New Medical Device Approval Process 19

5.1.3.1 Premarket Notification or 510(k) 21

5.1.3.2 Premarket Approval 23

5.1.3.3 Other Device Regulations 24

5.1.4 Quality System Regulation/Good Manufacturing Practices 24

5.1.5 Labeling 25

5.1.6 Medical Device Reporting 26

6 Changing Reimbursement Scenario in the Medical Device Market 28

6.1 Cardiovascular Devices 28

6.1.1 Reimbursement Coverage for Transcatheter Aortic Valve Replacement 28

6.1.1.1 Transcatheter Heart Valves Market in the US is Expected to Exceed $3 billion by 2019 at a CAGR of 45% 29

6.1.2 Reimbursement Coverage for Artificial Hearts and Related Devices 30

6.1.2.1 Left Ventricular Assist Devices Market in the US is Expected to More than Double during the Forecast Period 31

6.1.3 Reimbursement Coverage for Percutaneous Transluminal Angioplasty 32

6.2 Neurostimulation Devices 34

6.2.1 Reimbursement Coverage for Transcutaneous Electrical Nerve Stimulation 34

6.3 Diagnostic Imaging Devices 36

6.3.1 Reimbursement Coverage for Magnetic Resonance Imaging 36

6.3.2 Reimbursement Coverage for Positron Emission Tomography Scans 37

6.3.3 Reimbursement Cuts for Diagnostic Imaging Services 38

6.4 Endoscopy Devices 38

6.4.1 Reimbursement Coverage for Capsule Endoscope Systems 38

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